Cleared Traditional

Ureteral Stents (AF-D series)

K243039 · Alton (Shanghai) Medical Instruments Co., Ltd. · Gastroenterology & Urology
Jun 2025
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K243039 is an FDA 510(k) clearance for the Ureteral Stents (AF-D series), a Stent, Ureteral (Class II — Special Controls, product code FAD), submitted by Alton (Shanghai) Medical Instruments Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on June 18, 2025, 264 days after receiving the submission on September 27, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4620.

Submission Details

510(k) Number K243039 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2024
Decision Date June 18, 2025
Days to Decision 264 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FAD — Stent, Ureteral
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4620

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